Hot Topics: ME/CFS Newsletter February 27, 2013

From the Editor: This past month has seen an unprecedented amount of activity in the world of ME/CFS. The FDA's rejection of Ampligen generated more press coverage than we've seen since XMRV. Also heading the media line-up were Laura Hillenbrand's moving interview with the New York Times, Hillary Johnson's expose of the XMRV scandal, Nancy Klimas' coming out party, and presentations by some of the leading experts in the field of ME/CFS research and treatment. All in all, this was was an exciting month. It bears repeating.

The Ampligen Wars

Ampligen has received more attention from the ME/CFS community than any other treatment to date – and with good reason. It is the only drug, so far, that has been able to get the severely ill out of bed. So, when the current round of FDA-mandated trials was over, and Ampligen's manufacturer, Hemispherx Biopharma, asked for the drug's approval, we held our breaths. After all, we'd been waiting for 25 years, during which Hemispherx had been made to jump through more hoops than a circus dog. We all knew this was our last chance.

Bob Miller, a severely ill ME/CFS patient and activist, decided that in order to put public pressure on the FDA, it was time to take drastic action. A few days before the FDA's decision was due, he went on a hunger strike – a very risky proposition for someone with ME/CFS. The hunger strike served at least one of its ends; it garnered media attention and generated hundreds of letters, which were sent to the FDA.

It was not entirely surprising that a counter-attack was soon launched. A day before the FDA was to make its decision, the PACE group came out with a study that supposedly demonstrated that people with ME could be cured by a talk and a walk: Cognitive Behavioral Therapy and Graded Exercise. Notwithstanding the plethora of pseudo-scientific devices employed by this study to make it seem real, the study contained all the flaws of previous PACE studies – a poorly selected cohort, meaningless statistics, and conclusions that were not actually supported by the study's results. The study was a classic case of researchers inventing data to support an assumption. Or was it?

The debate over whether ME/CFS is in the body or in the mind is one which has serious economic ramifications. Those who put forth the argument that it's a mental illness, also propose treatments that are very cheap. Walking and talking cost almost nothing. But, if Ampligen had won its day in court, that argument would have been over. Had the FDA approved Ampligen, it would have constituted federal acknowledgment that ME/CFS is an organic illness. Insurance companies would then have been forced to cover treatment, which, because this is still a disease with “unknown etiology,” would inevitably have been enormously expensive. As far as insurance companies were concerned, Ampligen would have been a Pandora's box that would have eventually broken the bank.

We all know how the battle turned out. Ampligen was not approved, and Bob Miller is eating again. Whether or not anyone acknowledges it, the insurance companies have won the day. But though they (and everyone else who has a stake in keeping ME/CFS under wraps) have won this battle – they have not won the war. Bob Miller accomplished what he set out to do. We are all speaking with one voice. And the media are listening.

At the age of 19, Laura Hillenbrand contracted severe ME/CFS. She was bedridden for years, yet went on to write Seabiscuit, a New York Times best-seller which was later made into a blockbuster film. Hillenbrand was recently interviewed about her experience as an author with ME/CFS by the New York Times. She talked about how she became ill, how she coped with the illness, and how writing has helped her overcome her limitations. She has these moving words to share with the ME/CFS community:

"I had never been public about my illness at all before 'Seabiscuit.' I didn’t want to talk about it very much because I had the experience of being dismissed and ridiculed. People don’t understand this illness, and the name is so misleading. I realized I had this opportunity because I was going to be getting press attention for the book. I’m going to talk about it because I can. Maybe that will save the next person from going through what I did.”

“On the uncharacteristically cool morning of July 22, 2009, 24 scientists gathered at the National Institutes of Health in Bethesda, Maryland. The topic: a troubling new retrovirus called XMRV. A paper in the journal Science was about to implicate the virus as the cause of a devastating disease with a dismissive name: chronic fatigue syndrome...”

With her usual flair for telling a gripping tale, Hillary Johnson has once more inserted ME/CFS into the mainstream news. The March 2013 issue of Discover magazine features an article by Johnson, “The Shadow Virus,” in which she recounts the long fascinating story of XMRV. Combining clear explanations on how retroviruses work with an uncanny sense of drama, Johnson describes how the virus came into being (a lab contaminant), how a respected scientist, Judy Mikovits, was fooled and ultimately led off in handcuffs, how the ME/CFS community's hopes for a cause were once again stymied, and how all of this was a good thing. In her closing words, Johnson quotes eminent virologist, Ian Lipkin, the man who ultimately disproved XMRV's role in ME/CFS. “Right or wrong about this particular virus, she [Mikovits] deserves credit for awakening interest in CFS.”

Johnson, as always, is at the forefront in keeping that interest alive. Please write a brief letter to the editor of Discover magazine at editor@discovermagazine.com, congratulating them for their fine article, “The Shadow Virus.” The more interest the media perceives, the more likely ME/CFS will remain a newsworthy topic.

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“We Need to Be Believed”

In September 2012, researchers at the University of Manchester in Great Britain did something that has been long overdue. They conducted a “bottom-up” study. The researchers interviewed nine GPs, five nurses, four CFS/ME specialists, ten carers and sixteen patients, and made practical recommendations for clinicians based on the needs of the patients. Not surprisingly, the needs of the patients included “the need to be believed.” Patients expressed frustration with doctors and clinicians who told them that “we all get ME at some point in our lives.” The researchers recommended training, preferably online through an e-learning module, to challenge the unsympathetic attitudes held by some practitioners. They also recommended that the e-learning resource for GPs include a computer template to assist the diagnostic process. In addition, the module should raise awareness of the needs of carers and provide practical advice on how to both support the carer and involve them in the management of the patient.

The University of Manchester is to be congratulated for its much needed research and for proposing such a well-organized, practical solution to the ongoing problem of educating doctors and clinicians on the needs of patients with ME/CFS.

On January 26, the Institute for Neuro Immune Medicine hosted a patient conference in the DeSantis Center at Nova Southeastern University in Miami, Florida. The conference was a celebration of the February 12 opening of Nancy Klimas' new endeavor – a center focused on the treatment and management of ME/CFS. Dr. Klimas, an internationally recognized ME/CFS clinician and researcher, and Chair of Clinical Immunology at Nova Southeastern University, has devoted over 20 years to researching and treating ME/CFS.

The conference featured presentations by clinicians on managing the illness, the role of supportive carers, infection and autoimmunity, new treatments, and the goals and mission of the new center. Patients with ME/CFS and Gulf War Syndrome spoke as well, describing their own recoveries in a panel called “Voices of Hope.”

Understanding Brain Fog in CFS. People with CFS have many different symptoms, among them are disabling fatigue and the inability to concentrate; so-called “brain fog.” CFS subjects often have additional symptoms of orthostatic intolerance (OI) described as dizziness or light-headedness when they become upright. Patients with both CFS and OI may have decreased amounts of blood available to circulate to their head. The purpose of these studies is to investigate changes in brain blood flow that may be the cause of the mental clouding and memory loss that some CFS patients experience, and to determine whether they are related to rapid changes in posture. The study will be conducted at the New York Medical College. Testing involves tilt testing, N-back testing, a measure of working memory, attention, concentration, and information processing. Reimbursement is $150 per day for this testing, which may take place over several days. Further details of the research and representative consent forms can be found on http://www.syncope.org/

Read more about ongoing clinical trials in the New York City area HERE.

Actually the author's of the PACE trial are now saying that in order for GET and CBT to be done appropriately it must be done by trained specialist - cha ching although that is still less than drugs such as Ampligen or Rituximab. The "money" is in long term disability payments - if the disease can be "reversed" as some mind/body proponents advocate then disability wouldn't have to be paid. That is why it is a conflict of interest between several PACE authors and disability insurance.